Eisai Co., Ltd announced that the company's UK subsidiary Eisai Ltd. has received a marketing authorization approval for the anti-epileptic agent Inovelon indicated as adjunctive therapy in Lennox-Gastaut Syndrome (LGS) from the European Commission (EC).
Eisai Ltd. has submitted the marketing authorization application for Inovelon in March 2005 to the European Medicines Agency through the centralized procedure. In November 2006, the company received a positive opinion by the committee for Medicinal Products for Human Use, which was ratified by EC at this time.
Inovelon is a structurally novel compound that acts as a broad-spectrum anticonvulsant. The data used for approval by EC this time was based on the result from a clinical trial, which studied the drug's safety and efficacy in adjunctive treatment of LGS, a severe form of epilepsy that develops in early childhood. As a result of the trial, Inovelon exhibited significant reduction in seizure frequency compared to the placebo.
Eisai is currently enhancing its neurology franchise, which includes Aricept for treatment of Alzheimer's disease and anti-epilepsy agent Zonegran (zonisamide). With the approval of Inovelon, the company expects to make further contributions in fulfilling the needs of patients and improving benefits to patients and their families.